Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

Issue Date: July 31, 2025
Issued by: Center for Devices and Radiological Health
Topic(s): User Fees, Administrative / Procedural
Status: Final

Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

This final guidance updates the previous version of the guidance, titled “Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments,” issued on August 1, 2018. The guidance includes updates that describe how FDA will determine if a small business is experiencing “financial hardship,” which would make the business eligible for a waiver of their registration fee (“Small Business Registration Fee Waiver”). The guidance details the types of information an entity seeking the waiver may submit for FDA’s consideration in determining whether to grant the Small Business Registration Fee Waiver, including entities that are in jurisdictions without a national taxing authority. The guidance is also being updated to reflect the planned replacement of Forms 3602 and 3602A with a single combined form (Form 3602N).

Download the Guidance Document